Quality Systems Engineer
About The Position
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases arePrevention, treatment, and cure, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Position Overview We are currently accepting applications for the role of Quality System Engineer. The successful candidate will be tasked with developing, implementing, and maintaining quality management systems to ensure compliance with industry standards and regulatory requirements. This position will require collaboration with cross-functional teams to identify opportunities for improvement, and promote continuous improvement initiatives throughout the organization.
Requirements
- Bachelor’s degree in engineering, Quality Management, or a related field.
- At least three years of experience working with quality systems in a regulated industry.
- Comprehensive understanding of ISO, FDA, or other applicable standards.
- Strong analytical, problem-solving, and communication skills.
Nice To Haves
- Certification in quality management, such as Six Sigma or CQE, is preferred.
Responsibilities
- Design and oversee quality control processes and documentation to ensure accurate and consistent procedures are followed.
- Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards.
- Conduct internal and external audits, and support the implementation of corrective and preventive actions to address identified issues.
- Provide training and guidance to staff on quality system protocols, fostering a culture of quality throughout the team.
- Work closely with engineering, manufacturing, and regulatory teams to ensure the seamless integration of quality standards across departments.
- Manage and track Corrective and Preventive Actions (CAPA) and Non-Conformances (NC), ensuring timely resolution and documentation in accordance with regulatory requirements.
Benefits
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
